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Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)

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ClinicalTrials.gov Identifier: NCT01807403
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Procedure: Deep brain stimulation Phase 3

Detailed Description:

Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
Study Start Date : October 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Deep brain stimulation of subthalamic nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus
Procedure: Deep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Experimental: Deep brain stimulation of caudate nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation
Procedure: Deep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Experimental: Deep brain stimulation of nucleus accumbens
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.
Procedure: Deep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.



Primary Outcome Measures :
  1. Severity of symptoms after each phase [ Time Frame: 3 months ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale


Secondary Outcome Measures :
  1. Severity of symptoms after each phase [ Time Frame: month 0 ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale

  2. Severity of symptoms after each phase [ Time Frame: 6 months ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale

  3. Severity of symptoms after each phase [ Time Frame: 10 months ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale

  4. Severity of symptoms after each phase [ Time Frame: 14 months ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Age 18 - 60
  • OCD according to DSM IV, at least 5 years since diagnosis
  • Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score>25, CGI score >= 4 and EGF score <= 40
  • Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
  • Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
  • Oral and written knowledge of French
  • Social security coverage
  • Written consent of the patient after clear description of the study

Exclusion criteria :

  • cognitive alteration with PM38 score < IQ85
  • Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
  • suicidal risk >=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
  • Personality disorder (axis 2 of DSM IV assessed using the SCID II)
  • Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
  • Fertile woman without adequate contraception
  • Pregnancy
  • Forced psychiatric hospitalisation
  • Any kind of legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807403


Locations
France
Centre d'investigation Clinique Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Luc Mallet, MD, PhD Assitance Publique - Hopitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01807403     History of Changes
Other Study ID Numbers: P081203
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obsessive-Compulsive Disorder
Deep brain stimulation
Subthalamic nucleus
Caudate nucleus
Nucleus accumbens

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders